BS EN 12306-1998 生物技术.农业,植物和动物传染病控制和环境污染用的随身携带诊断仪的质量控制指南

标准号：BS EN 12306-1998
中文标准名称：生物技术.农业,植物和动物传染病控制和环境污染用的随身携带诊断仪的质量控制指南
英文标准名称：Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
标准类型：B91
发布日期：1998/3/15 12:00:00
实施日期：1998/3/15 12:00:00
中国标准分类号：B91
国际标准分类号：07.080;07.100.99
适用范围：This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to micro-organisms. This standard does not apply to diagnostic kits used either in the food industry or for human health monitoring, or control of non-biological contaminants. This European Standard does not concern single kit components such as reagents (i.e. monoclonal or polyclonal antibodies) or materials (i.e. ELISA plate). This standard does not concern any specific diagnostic method (such as ELISA, Dot blot, DNA probe). This European Standard does not aim to establish a system of quality assurance but it is recommended that quality control procedures are in accordance with a system of quality assurance such as EN ISO 9000 series.